FDA Box Warning

• Give drug under supervision of physician experienced in immunosuppressive therapy for treatment of renal transplant or asplastic anemia patients, in facility with adequate laboratory and supportive resources

Precautions

Administration

☞ Know that drug should be given only by health care professionals experienced in immunosuppressive therapy for treating aplastic anemia or renal transplant patients, in facilities equipped and staffed with adequate laboratory and supportive resources.

☞ Because of high risk of anaphylaxis, perform intradermal skin test before first dose. Inject 0.1-ml dose of 1:1,000 dilution of LIG intradermally; a control test using 0.9% sodium chloride injection is injected contralaterally. Observe site every 15 to 20 minutes during first hour after injection, and monitor patient for systemic manifestations. Local reaction of 10 mm or greater with wheal, erythema, or both (with or without pseudopod formation and itching or marked local swelling) indicates positive test (which warrants consideration of alternate therapy). Systemic reaction (such as tachycardia, dyspnea, hypotension, or anaphylaxis) precludes LIG therapy.• Premedicate with antipyretic, antihistamine, or corticosteroid, as prescribed, to minimize reactions.• For I.V. infusion, dilute prescribed dose in 250 to 1,000 ml of 0.45% or 0.9% sodium chloride injection. (Don't dilute in dextrose solutions or highly acidic solutions.) Final concentration shouldn't exceed 4 mg/ml. Infuse total daily dose over at least 4 hours.• When adding drug to infusion container, invert container so air doesn't enter. Gently swirl or rotate container to mix solution.• Using in-line filter with pore size of 0.2 to 1 micron, infuse into central vein, shunt, or arteriovenous fistula over at least 4 hours.• Be aware that drug is usually given concurrently with azathioprine and corticosteroids when used for allograft rejection.

Interactions

Patient monitoring

☞ During infusion, watch for signs and symptoms of hypersensitivity reaction, such as rash, respiratory distress, or chest, flank, or back pain. Be aware that this reaction may occur even with a negative skin test.

☞ Discontinue drug if renal transplant patient develops signs or symptoms of anaphylaxis or severe thrombocytopenia or leukopenia.• Be aware that product derives from equine and human blood components and may transmit infections.• Monitor for signs and symptoms of infection, such as fever, malaise, and sore throat (caused by immunosuppression).

Patient teaching

☞ Tell patient to immediately report adverse reactions during infusion (such as pain at infusion site) as well as systemic complaints (such as easy bruising or bleeding or signs of hypersensitivity reaction).• Instruct patient to avoid sources of infection, such as people with known infections. Tell him to promptly report signs or symptoms of infection.

☞ Caution female patient not to take drug if she is pregnant.• Tell female patient to inform prescriber if she is breastfeeding.• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

lymphocyte immune globulin

(lim-foe-site im-myoon glo-byoo-lin) ,

ATG

(trade name),

antilymphocyte globulin

(trade name),

Atgam

(trade name),

LIG

(trade name)

Classification

Therapeutic: immunosuppressants Pharmacologic: immune globulins

Pregnancy Category: C

Indications

Management of allograft rejection in renal transplant patients.Treatment of aplastic anemia in patients who are not candidates for bone marrow transplantation.

Action

Decreases the circulating number of T lymphocytes, which are involved in both cell-mediated and humoral immunity.

Therapeutic effects

Resolution of rejection of renal allografts.

Remission of aplastic anemia.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 5.7 days.

Time/action profile (decreased circulating T lymphocytes)

ROUTE

ONSET

PEAK

DURATION

IV

rapid

unknown

unknown

Contraindications/Precautions

Contraindicated in: History of hypersensitivity during previous courses of therapy or systemic reaction to skin testing; Hypersensitivity to thimerosal; Hypersensitivity to equine gamma globulin preparations.

Lab Test Considerations: Monitor CBC and platelets throughout therapy. May cause leukopenia and thrombocytopenia. Thrombocytopenia is usually transient and does not normally require discontinuation of therapy or transfusion.

May also cause hemolysis. Treatment includes transfusion of erythrocytes and administration of mannitol, furosemide, sodium bicarbonate, and fluids, if necessary.

Potential Nursing Diagnoses

Risk for infection (Indications, Side Effects)

Implementation

Medication should be used only by physicians experienced in immunosuppressive therapy and management of renal transplant patients and should be administered only in facilities equipped and staffed with adequate laboratory and medical resources.

Patients with aplastic anemia may need a transfusion of platelets before administration to maintain platelets at a clinically acceptable level.

Test Dose: Administer an intradermal injection of 0.1 mL of a 1:1000 dilution in 0.9% NaCl and a 0.9% NaCl control. If a wheal or erythema >10 mm forms with or without a pseudopod and itching or a marked local swelling occurs, administer infusion with caution. If a systemic reaction (generalized rash, tachycardia, dyspnea, hypotension, anaphylaxis) occurs, do not administer infusion. Allergic reactions may occur in patients with a negative reaction to test dose.

Intravenous Administration

Intermittent Infusion: Diluent: Dilute total daily dose in 0.45% NaCl or 0.9% NaCl. Concentration: Not to exceed 1 mg/mL. Invert IV saline bottle so that undiluted drug does not come in contact with the air inside. May be infused through an in-line filter with a pore size of 0.2–1 micron. Refrigerate diluted solution if prepared before administration. Do not freeze; discard if frozen. Stable for 24 hr, including infusion time, if refrigerated.

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